The US Oncology Network <thenetwork@mshinfo.mckesson.com>
`To: Trinidad, Audrey <Audrey.Trinidad@McKesson.com>
`TEST | Sponsored Message: Genentech Shares Trial Results by Hormone Receptor Status in
`HER2+ MBC
`
`May 9, 2014 10:10 AM
`
`
`
`To view this email as a web page, click here
`
`Sponsored Message:
`Genentech shares trial results by hormone receptor status
`in HER2+ MBC
`
`In the phase III EMILIA trial of KADCYLA® (ado-trastuzumab emtansine), vs
`lapatinib + capecitabine (N=991)…
`KADCYLA demonstrated survival benefit for patients, including
`both ER/PR+ and ER/PR- subgroups
`Indication
`KADCYLA® (ado-trastuzumab emtansine), injection for intravenous use, as a single
`agent, is indicated for the treatment of patients with HER2-positive (HER2+), metastatic
`breast cancer (MBC) who previously received trastuzumab and a taxane, separately or
`in combination. Patients should have either:
`
`Received prior therapy for metastatic disease, or
`Developed disease recurrence during or within six months of completing adjuvant
`therapy
`
`SELECTED PATIENT SUBGROUPS/TREATMENT BENEFIT BY HR (EMILIA TRIAL)1
`
`IMMUNOGEN 2341, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`To: Trinidad, Audrey <Audrey.Trinidad@McKesson.com>
`TEST | Sponsored Message: Genentech Shares Trial Results by Hormone Receptor Status in
`HER2+ MBC
`
`May 9, 2014 10:10 AM
`
`
`
`To view this email as a web page, click here
`
`Sponsored Message:
`Genentech shares trial results by hormone receptor status
`in HER2+ MBC
`
`In the phase III EMILIA trial of KADCYLA® (ado-trastuzumab emtansine), vs
`lapatinib + capecitabine (N=991)…
`KADCYLA demonstrated survival benefit for patients, including
`both ER/PR+ and ER/PR- subgroups
`Indication
`KADCYLA® (ado-trastuzumab emtansine), injection for intravenous use, as a single
`agent, is indicated for the treatment of patients with HER2-positive (HER2+), metastatic
`breast cancer (MBC) who previously received trastuzumab and a taxane, separately or
`in combination. Patients should have either:
`
`Received prior therapy for metastatic disease, or
`Developed disease recurrence during or within six months of completing adjuvant
`therapy
`
`SELECTED PATIENT SUBGROUPS/TREATMENT BENEFIT BY HR (EMILIA TRIAL)1
`
`IMMUNOGEN 2341, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Category
`
`All patients
`
`Hormone receptor status
`Positive (ER+ and/or PR+)
`Negative (ER- and PR-)
`
`n
`
`991
`
`545
`426
`
`PFS
`
`OS
`
`95% CI
`
`HR
`Estimate
`0.55, 0.77
`0.65
`P<0.0001
`
`95% CI
`
`HR
`Estimate
`0.55, 0.85
`0.68
`P=0.0006
`
`0.72
`0.56
`
`0.58, 0.91
`0.44, 0.72
`
`0.62
`0.75
`
`0.46, 0.85
`0.54, 1.03
`
`CI=confidence interval; HR=hazard ratio; OS=overall survival; PFS=progression-free
`survival.
`ER=estrogen receptor; PR=progesterone receptor.
`
`For more information about the EMILIA trial,
`visit KADCYLA.com.
`
`
`Important Safety Information
`Boxed WARNINGS: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO -FETAL
`TOXICITY
`
`Do Not Substitute KADCYLA for or with Trastuzumab
`Hepatotoxicity: Serious hepatotoxicity has been reported, including liver
`failure and death in patients treated with KADCYLA. Monitor serum
`transaminases and bilirubin prior to initiation of KADCYLA treatment and
`prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA as
`appropriate in cases of increased serum transaminases or total bilirubin
`Cardiac Toxicity: KADCYLA administration may lead to reductions in left
`ventricular ejection fraction (LVEF). Evaluate left ventricular function in all
`patients prior to and during treatment with KADCYLA. Withhold treatment
`for clinically significant decrease in left ventricular function
`Embryo-Fetal Toxicity: Exposure to KADCYLA can result in embryo-fetal
`death or birth defects. Advise patients of these risks and the need for
`effective contraception
`
`Additional Important Safety Information
`Left Ventricular Dysfunction (LVD)
`
`Patients treated with KADCYLA are at increased risk of developing LVD. In
`EMILIA, LVD occurred in 1.8% of patients in the KADCYLA-treated group and in
`
`IMMUNOGEN 2341, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`3.3% in the comparator group. Permanently discontinue KADCYLA if LVEF has
`not improved or has declined further
`
`Pregnancy Registry
`
`Advise patients to contact their healthcare provider immediately if they suspect
`they may be pregnant. Encourage women who may be exposed to KADCYLA
`during pregnancy to enroll in the MotHER Pregnancy Registry by contacting 1-
`800-690-6720
`
`Pulmonary Toxicity
`
`Cases of interstitial lung disease (ILD), including pneumonitis, some leading to
`acute respiratory distress syndrome or fatal outcome have been reported in
`clinical trials with KADCYLA. In EMILIA, the overall frequency of pneumonitis was
`1.2%
`Treatment with KADCYLA should be permanently discontinued in patients
`diagnosed with ILD or pneumonitis
`
`Infusion-Related Reactions, Hypersensitivity Reactions
`
`Treatment with KADCYLA has not been studied in patients who had trastuzumab
`permanently discontinued due to infusion-related reactions (IRR) and/or
`hypersensitivity reactions; treatment with KADCYLA is not recommended for
`these patients. In EMILIA, the overall frequency of IRRs in patients treated with
`KADCYLA was 1.4%
`KADCYLA treatment should be interrupted in patients with severe IRR and
`permanently discontinued in the event of a life-threatening IRR. Patients should
`be closely monitored for IRR reactions, especially during the first infusion
`
`Thrombocytopenia
`
`In EMILIA, the incidence of ≥ Grade 3 thrombocytopenia was 14.5% in the
`KADCYLA-treated group and 0.4% in the comparator group (overall incidence
`31.2% and 3.3%, respectively)
`Monitor platelet counts prior to initiation of KADCYLA and prior to each KADCYLA
`dose. Institute dose modifications as appropriate
`
`Neurotoxicity
`
`In EMILIA, the incidence of ≥ Grade 3 peripheral neuropathy was 2.2% in the
`KADCYLA-treated group and 0.2% in the comparator group (overall incidence
`21.2% and 13.5%, respectively)
`Monitor for signs or symptoms of neurotoxicity. KADCYLA should be temporarily
`
`IMMUNOGEN 2341, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`discontinued in patients experiencing Grade 3 or 4 peripheral neuropathy until
`resolution to ≤ Grade 2
`
`HER2 Testing
`
`Detection of HER2 protein overexpression or gene amplification is necessary for
`selection of patients appropriate for KADCYLA. Perform using FDA approved
`tests by laboratories with demonstrated proficiency
`
`Extravasation
`
`In KADCYLA clinical studies, reactions secondary to extravasation have been
`observed and were generally mild. The infusion site should be closely monitored
`for possible subcutaneous infiltration during drug administration. Specific
`treatment for KADCYLA extravasation is unknown
`
`Nursing Mothers
`
`Discontinue nursing or discontinue KADCYLA taking into consideration the
`importance of the drug to the mother
`
`Adverse Reactions
`
`The most common ADRs seen with KADCYLA in EMILIA (frequency > 25%) were
`nausea, fatigue, musculoskeletal pain, thrombocytopenia, increased
`transaminases, headache, and constipation. The most common NCI-CTCAE
`(version 3) ≥ Grade 3 ADRs (frequency >2%) were thrombocytopenia, increased
`transaminases, anemia, hypokalemia, peripheral neuropathy and fatigue
`
`You are encouraged to report side effects to Genentech and the FDA. You may contact
`Genentech by calling 1-888-835-2555. You may contact the FDA by
`visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
`
`Please download the full Prescribing Information for additional important safety
`information, including Boxed WARNINGS.
`
`For more information on KADCYLA, visit KADCYLA.com.
`TDM0002481700 (05/14)
`
`Reference: 1. KADCYLA Prescribing Information. Genentech, Inc. May 2013.
`
`Privacy Policy | Terms and Conditions | Contact Genentech®
`
`This e-mail is intended for U.S. healthcare professionals only.
`
`
`IMMUNOGEN 2341, pg. 4
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Genentech, Inc.
`1 DNA Way
`South San Francisco, CA
`94080-4990
`
` ©
`
` 2014 Genentech USA, Inc. All rights reserved.
`
`This email is meant to keep The US Oncology Network up to date on news, developments and other information. This communication is for internal use
`only, intended for the information of The Network and corporate employees.
`
`
`
`This email was sent to audrey.califf@mckesson.com. If you no longer wish to receive these emails you may
`unsubscribe at any time.
`
`IMMUNOGEN 2341, pg. 5
`Phigenix v. Immunogen
`IPR2014-00676
`
`
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